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INSYS Therapeutics Inc (INSY.OQ)

INSY.OQ on NASDAQ Stock Exchange Global Market

8.69USD
19 Jan 2018
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Latest Key Developments (Source: Significant Developments)

Insys' Treatment For Prader-Willi Syndrome Gets ‘Fast Track’ Designation
Tuesday, 26 Dec 2017 

Dec 26 (Reuters) - Insys Therapeutics Inc ::FDA GRANTS INSYS THERAPEUTICS ‘FAST TRACK’ DESIGNATION FOR CANNABIDIOL (CBD) ORAL SOLUTION AS INVESTIGATIONAL TREATMENT FOR PRADER-WILLI SYNDROME.INSYS THERAPEUTICS - PLAN TO START CLINICAL DEVELOPMENT PROGRAM FOR CANNABIDIOL ORAL SOLUTION IN LATE Q1 OF 2018.  Full Article

Insys Therapeutics Inc - ‍Study Is Expected To Be Completed In Late 2018 For Of Cbd Oral Solution-A​
Tuesday, 19 Dec 2017 

Dec 19 (Reuters) - Insys Therapeutics Inc ::INSYS THERAPEUTICS INITIATES PHASE 2 CLINICAL TRIAL OF CANNABIDIOL (CBD) ORAL SOLUTION FOR TREATMENT OF REFRACTORY CHILDHOOD ABSENCE EPILEPSY IN PEDIATRIC PATIENTS.INSYS THERAPEUTICS INC - ‍STUDY IS EXPECTED TO BE COMPLETED IN LATE 2018 FOR OF CBD ORAL SOLUTION-A​.  Full Article

Insys Therapeutics' NDA For Buprenorphine Sublingual Spray Accepted By FDA
Wednesday, 6 Dec 2017 

Dec 6 (Reuters) - Insys Therapeutics Inc ::FDA ACCEPTS NEW DRUG APPLICATION (NDA) FOR BUPRENORPHINE SUBLINGUAL SPRAY FROM INSYS THERAPEUTICS.SAYS ‍UNDER PDUFA, FDA HAS SET TARGET DATE OF JULY 28, 2018 TO COMPLETE REVIEW OF NDA FOR BUPRENORPHINE SUBLINGUAL SPRAY​.SAYS ‍DATA FROM RECENTLY COMPLETED 7-DAY SAFETY & TOLERABILITY STUDY TO BE SUBMITTED TO FDA IN Q1 2018, MAY IMPACT PDUFA DATE​.  Full Article

Insys Therapeutics reports Q3 loss per share of $2.30
Thursday, 2 Nov 2017 

Nov 2 (Reuters) - Insys Therapeutics Inc :Insys therapeutics reports third quarter 2017 results.Q3 loss per share $2.30.Q3 revenue $48.9 million.Q3 revenue view $35.5 million -- Thomson Reuters I/B/E/S.Q3 earnings per share view $-0.16 -- Thomson Reuters I/B/E/S.Insys therapeutics inc qtrly ‍net revenue was unfavorably impacted by approximately $5 million due to product returns​.Insys therapeutics inc qtrly ‍ gross revenue was $48.9 million, resulting in net revenue of $30.7 million​.  Full Article

Insys Therapeutics provides update on NASDAQ trading hold
Monday, 30 Oct 2017 

Oct 30 (Reuters) - Insys Therapeutics Inc ::Insys Therapeutics provides update on NASDAQ trading hold.Subsequent to trading hold placed on stock on Thursday after market close, received series of questions on Friday from NASDAQ​.Questions received from NASDAQ on Oct 27 have been addressed, co is awaiting response from NASDAQ regarding resumption of trading​.  Full Article

Insys Therapeutics reports preliminary estimated revenues from Subsys for Q3 2016 to be $54 mln -$55 mln
Thursday, 13 Oct 2016 

Insys Therapeutics Inc : Insys Therapeutics reports preliminary estimated revenues from subsys for the third quarter 2016 . Insys Therapeutics Inc - preliminary estimated revenues from Subsys (fentanyl sublingual spray) for Q3 of 2016 will be in range of $54 million to $55 million . Insys Therapeutics Inc- company believes it will be cash-flow positive at the level of sales . Insys Therapeutics Inc - "estimated revenues for quarter reflect a decline in prescriptions" .Insys Therapeutics-believes scrutiny resulted in patients having difficulty getting reimbursement for transmucosal immediate release fentanyl medications.  Full Article

Insys Therapeutics Q2 earnings per share $0.06
Wednesday, 3 Aug 2016 

Insys Therapeutics Inc : Q2 adjusted non-gaap earnings per share $0.13 . Q2 revenue $67.1 million versus i/b/e/s view $66.9 million . Insys therapeutics reports second quarter 2016 results . Q2 earnings per share $0.06 .Q2 earnings per share view $0.07 -- Thomson Reuters I/B/E/S.  Full Article

Insys Therapeutics announces FDA approval of Syndros
Tuesday, 5 Jul 2016 

Insys Therapeutics Inc : Syndros is currently awaiting scheduling by U.S. Drug Enforcement Administration . Company anticipates launching Syndros in second half of 2016 . Syndros is approved for use in treating anorexia associated with weight loss in patients with AIDS . Insys therapeutics announces FDA approval of Syndros .Syndros is also approved for use in treating nausea, vomiting associated cancer chemotherapy in patients.  Full Article

Kessler Topaz Meltzer & Check, LLP Files Shareholder Class Action Against Insys Therapeutics Inc - ACSWIR
Saturday, 6 Feb 2016 

Insys Therapeutics Inc:The law firm of Kessler Topaz Meltzer & Check, LLP announces that it has filed a shareholder class action lawsuit against Insys Therapeutics on behalf of purchasers of the Company's securitiesbetween March 3, 2015 and January 25, 2016 - ACSWIR.The shareholder class action complaint alleges that Insys and certain of its executive officers made a series of false and misleading statements, and failed to disclose material adverse facts, about the Company's business and operations to investors during the Class Period.Specifically, the defendants are alleged to have failed to disclose that the Company was engaged in the illegal and improper off-labeling marketing of Subsys;.certain Insys employees - including Defendant Michael L. Babich, the President and Chief Executive Officer of Insys during much of the Class Period - were complicit in an illegal kickback scheme operated for the purpose of increasing prescriptions of Subsys.as a result, the Company's financial statements were materially false and misleading at all relevant times.  Full Article

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Ex-Insys employee seeks ban on mentioning 'opioid crisis' at trial

A former Insys Therapeutics Inc employee accused of engaging in a scheme to pay medical practitioners kickbacks to prescribe a fentanyl-based treatment is seeking to bar U.S. prosecutors from referring to the "opioid crisis" at his trial.